Clinical studies can give you access to breakthrough treatments --- but know the risks

By
Harvard Health Letters

JewishWorldReview.com |
In January 2007, Debbera Drake got the news every woman dreads. She had stage-four breast cancer. One doctor she'd sought for a second opinion told her she had just two years to live.

After Drake underwent chemotherapy, radiation, and surgery, her oncologist, Dr. Beverly Moy at Massachusetts General Hospital, suggested she take part in a clinical trial for a new breast cancer inhibitor drug. In December 2008, she enrolled in the study.

Four years after Drake started taking the experimental therapy, her cancer is stable. At age 67, she's survived three years longer than her original prognosis.

"Dr. Moy said that no one has lived this long with this type of cancer, so I'm now kind of setting the standard," she says.

Of the clinical trial that may have extended her life, she says, "It has given me hope."

WHY TAKE PART IN CLINICAL TRIALS?
For anyone faced with a serious diagnosis, as Drake was, clinical trials can offer an alternative to the current treatments available. Being part of a study gives you access to breakthrough therapies and a highly trained team of doctors, nurses, and technicians to guide you through those therapies. Many trials cover the cost of medical treatment, and some may even compensate you for your participation.

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For researchers like Dr. Manson, clinical studies provide a controlled setting in which to compare the effectiveness of new therapies or prevention strategies against those currently in use. What they learn from these studies can be used to develop new and potentially more effective ways to treat or prevent illnesses, helping large numbers of people.

"When people participate in randomized clinical trials, they are advancing science and helping to get important answers," Dr. Manson says.

You don't need to have a life-threatening disease--like Drake did--to take part in a clinical study. In fact, you don't need to be sick at all. Researchers are always looking for healthy study subjects to test strategies for keeping people well and preventing disease.

Women in particular can benefit from taking part in research studies, because they tend to be underrepresented in clinical trials.

"It's very important that women get involved in randomized clinical trials so that researchers can find treatment and prevention strategies that work for women and are tailored to their needs," Dr. Manson says.

TYPES OF STUDIES
If you enroll in a clinical trial, you may hear your doctor refer to it as "randomized" or "observational." Just what do these terms mean?

During a randomized trial, one group of participants is randomly assigned to receive the treatment being studied, while another group (or groups) receives either a different treatment or an inactive pill called a placebo.

If the study is double-blind, neither the participants nor the doctors and nurses involved know which treatment each person is receiving. This prevents anyone involved from biasing the results.

In an observational study, participants aren't given any specific treatment, but researchers observe them to see how their lifestyle habits relate to their health.

WHAT ARE THE RISKS?
Researchers who design and implement clinical studies must follow strict rules that ensure every participant is as safe as possible. Yet despite all the precautions, there's always a risk with new--or even established--treatments that you might have an adverse effect. Those risks can include the side effects of the treatment, as well as the chance that it won't work for you, or that you'll receive a placebo instead of the active therapy.

If you enroll in a study, you'll be asked to sign an informed consent statement, which outlines all of the potential risks involved in participating, as well as the potential benefits.

"You want to be sure that you read the informed consent," Dr. Manson advises. "Be sure you understand what the trial involves and what your participation requires."

To find a clinical trial in your area, visit www.clinicaltrials.gov. Type your condition and location into the search box (for example, "breast cancer AND Atlanta"), and the site will bring up a list of clinical trials that are recruiting in your area.

ASKING THE RIGHT QUESTIONS
Before enrolling in any clinical trial, here are a few key questions to ask the research team:

1. What is the purpose of this study?

2. How will the study benefit me?

3. What are other treatment options?

4. How long is the study?

5. Has this treatment been tested before? What were the results?

6. What kinds of tests and treatments will I receive?

7. How will I know whether the treatment is working?

8. What kinds of follow-up tests and treatments will be done?

9. What are the risks?

10. What is my risk if I get usual care instead of the treatment? - Harvard Women's Health Watch

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